New Zealand, like many countries, struggles with medicines shortages. This issue
increased during the height of the Covid-19 pandemic and unfortunately appears
to be here to stay.
New Zealand has a unique medicine funding model – Pharmac is the government agency which decides what medicines and related products are publicly funded. Its
sole supply model means a single pharmaceutical company becomes the exclusive supplier nationwide, securing lower prices but increasing vulnerability to supply disruption.
When that supplier experiences issues, every pharmacy and patient is affected. Pharmac also maintains the Pharmaceutical Schedule, updated monthly with funding, access and dispensing rules.
Unapproved medicines
Ongoing shortages have increased the need for unapproved medicines — products not approved by Medsafe but able to be supplied when prescribed for individual patients. These medicines are added to the Pharmaceutical Schedule temporarily and require additional work from both prescribers and pharmacists.
Changes to who can prescribe
Recent changes in the Medicines Amendment Bill expanded who may prescribe unapproved medicines. Nurse prescribers and pharmacist prescribers may now prescribe any unapproved medicine, alongside medical practitioners.
Auhorised prescribers may prescribe unapproved medicines only when Pharmac funds them as alternatives to approved medicines in short supply. Authorised prescribers include anyone with prescribing rights under the Health Practitioners Competence Assurance Act 2003.
Practical issues
Pharmacists may only import an unapproved medicine for a known patient and cannot transfer stock to another pharmacy. Expired stock must be reported to the importer. Prescribers must obtain patient consent, explain supporting evidence and safety considerations, and advise that information will be provided to the Director-General of Health.
Prescribers' systems
Prescriber management systems are not updated as frequently as pharmacy systems. This can result in prescribers unknowingly issuing prescriptions for medicines that have been replaced by unapproved versions, creating legal and ethical risks.
Supply issues
Supply changes mid-prescription can cause confusion. A prescriber may expect an approved medicine to be supplied, unaware that a substitution to an unapproved
brand may occur later. This creates uncertainty for pharmacists about how to manage these situations.
Uncertainty
Pharmacists must obtain prescriber authorisation before supplying an unapproved medicine, yet practices vary and Medsafe has not provided clear guidance outlining pharmacists’ obligations.
Lack of information
Unapproved medicines do not have datasheets, making clinical decision-making more difficult. Prescribers and pharmacists may also have differing assumptions about Pharmac’s due diligence, leading some to believe they do not need to independently verify appropriateness.
Rules lead to delays
Pharmacies cannot procure unapproved medicines in anticipation of a prescription, causing delays in treatment. Repeat supplies require patient-initiated requests, often
resulting in frustration from patients unaware of the legal and ethical requirements pharmacies must meet.
As more unapproved medicines are funded, community pharmacies are facing an increased workload, uncertainty of their obligations and pressure from frustrated patients.
The Medical Products Bill, currently in development, aims to address these issues. The Guild HQ team continues to engage with the Ministry of Health, and members
will be kept updated as this work progresses.